Laminated patient infusion device

ABSTRACT

A device for delivering fluid to a patient including an exit port assembly adapted to connect to a transcutaneous patient access tool, and a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway for controlling fluid flow from a reservoir to the exit port assembly. The laminated construction provides many benefits including simplifying the design and manufacturing of the device, in order to further reduce the size, complexity and costs of the device so that the device lends itself to being small and disposable in nature.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to U.S. patent application Ser. No.09/943,992, filed on Aug. 31, 2001, which is assigned to the assignee ofthe present application and incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, systems andmethods, and more particularly to small, low cost, portable infusiondevices and methods that are useable to achieve precise, sophisticated,and programmable flow patterns for the delivery of therapeutic liquidsto a mammalian patient.

BACKGROUND OF THE INVENTION

Today, there are numerous diseases and other physical ailments that aretreated by various medicines including pharmaceuticals, nutritionalformulas, biologically derived or active agents, hormonal and gene basedmaterial and other substances in both solid or liquid form. In thedelivery of these medicines, it is often desirable to bypass thedigestive system of a mammalian patient to avoid degradation of theactive ingredients caused by the catalytic enzymes in the digestivetract and liver. Delivery of a medicine other than by way of theintestines is known as parenteral delivery. Parenteral delivery ofvarious drugs in liquid form is often desired to enhance the effect ofthe substance being delivered, insuring that the unaltered medicinereaches its intended site at a significant concentration. Also,undesired side effects associated with other routes of delivery, such assystemic toxicity, can potentially be avoided.

Often, a medicine may only be available in a liquid form, or the liquidversion may have desirable characteristics that cannot be achieved withsolid or pill form. Delivery of liquid medicines may best beaccomplished by infusing directly into the cardiovascular system viaveins or arteries, into the subcutaneous tissue or directly into organs,tumors, cavities, bones or other site specific locations within thebody.

Parenteral delivery of liquid medicines into the body is oftenaccomplished by administering bolus injections using a needle andreservoir, or continuously by gravity driven dispensers or transdermalpatch technologies. Bolus injections often imperfectly match theclinical needs of the patient, and usually require larger individualdoses than are desired at the specific time they are given. Continuousdelivery of medicine through gravity feed systems compromise thepatient's mobility and lifestyle, and limit the therapy to simplisticflow rates and profiles. Transdermal patches have special requirementsof the medicine being delivered, particularly as it relates to themolecular structure, and similar to gravity feed systems, the control ofthe drug administration is severely limited.

Ambulatory infusion pumps have been developed for delivering liquidmedicaments to a patient. These infusion devices have the ability tooffer sophisticated fluid delivery profiles accomplishing bolusrequirements, continuous infusion and variable flow rate delivery. Theseinfusion capabilities usually result in better efficacy of the drug andtherapy and less toxicity to the patient's system. An example of a useof an ambulatory infusion pump is for the delivery of insulin for thetreatment of diabetes mellitus. These pumps can deliver insulin on acontinuous basal basis as well as a bolus basis as is disclosed in U.S.Pat. No. 4,498,843 to Schneider et al.

The ambulatory pumps often work with a reservoir to contain the liquidmedicine, such as a cartridge or reservoir, and use electro-mechanicalpumping or metering technology to deliver the medication to the patientvia tubing from the infusion device to a needle that is insertedtranscutaneously, or through the skin of the patient. The devices allowcontrol and programming via electromechanical buttons or switcheslocated on the housing of the device, and accessed by the patient orclinician. The devices include visual feedback via text or graphicscreens, such as liquid crystal displays known as LCD's, and may includealert or warning lights and audio or vibration signals and alarms. Thedevice can be worn in a harness or pocket or strapped to the body of thepatient.

Currently available ambulatory infusion devices are expensive, difficultto program and prepare for infusion, and tend to be bulky, heavy andvery fragile. Filling these devices can be difficult and require thepatient to carry both the intended medication as well as fillingaccessories. The devices require specialized care, maintenance, andcleaning to assure proper functionality and safety for their intendedlong term use. Due to the high cost of existing devices, healthcareproviders limit the patient populations approved to use the devices andtherapies for which the devices can be used.

Clearly, therefore, there was a need for a programmable and adjustableinfusion system that is precise and reliable and can offer cliniciansand patients a small, low cost, light weight, simple to use alternativefor parenteral delivery of liquid medicines.

In response, the applicant of the present application provided a small,low cost, light weight, easy to use device for delivering liquidmedicines to a patient. The device, which is described in detail inco-pending U.S. application Ser. No. 09/943,992, filed on Aug. 31, 2001,includes an exit port, a dispenser for causing fluid from a reservoir toflow to the exit port, a local processor programmed to cause a flow offluid to the exit port based on flow instructions from a separate,remote control device, and a wireless receiver connected to the localprocessor for receiving the flow instructions. To reduce the size,complexity and costs of the device, the device is provided with ahousing that is free of user input components, such as a keypad, forproviding flow instructions to the local processor.

What is still desired are new and improved devices for delivering fluidto a patient. Preferably, the fluid delivery devices will be simple indesign, and inexpensive and easy to manufacture, in order to furtherreduce the size, complexity and costs of the devices, such that thedevices lend themselves to being small and disposable in nature.

SUMMARY OF THE INVENTION

In response, the present invention provides a device for deliveringfluid to a patient, including an exit port assembly adapted to connectto a transcutaneous patient access tool, and a dispenser including atleast two laminated layers of material defining a passageway connectedto the exit port assembly, and an expandable accumulator in fluidcommunication with the passageway for controlling fluid flow from areservoir to the exit port assembly. The laminated construction providesmany benefits including, but not limited to, simplifying the design andmanufacturing of the device, and further reducing the size, complexityand costs of the device. The device of the present invention, therefore,lends itself to being small and disposable in nature.

According to one aspect of the present invention, at least one layer ofthe dispenser comprises a resilient diaphragm. According to anotheraspect, the at least two laminated layers of the dispenser furtherinclude a first layer and a second layer received against the firstlayer. The second and the first layers define the passageway connectedto the exit port assembly, and the second layer includes an opening influid communication with the passageway. The resilient diaphragm isreceived on the second layer covering the opening, and a third layer isreceived over the diaphragm on the second layer. The third layer has anpulse chamber over the diaphragm and in alignment with the opening ofthe second layer, and a port in fluid communication with the pulsechamber.

According to another aspect, one of the second and the third layersdefines a recess receiving the diaphragm, and wherein the recess has adepth about equal to a thickness of the diaphragm such that thediaphragm is secured in a substantially fluid-tight manner between thesecond and the third layers. Preferably, a length and a width of therecess are greater than a length and a width of the diaphragm in orderto decrease required manufacturing tolerances of the dispenser.

According to an additional embodiment of the present invention, the atleast two laminated layers include a first layer, and a second layerreceived against the first layer. The second and the first layers definethe passageway connected to the exit port assembly. The second layerincludes a surface facing away from the first layer and having a recess,and an opening providing fluid communication between the recess and thepassageway defined by the first and the second layers. The resilientdiaphragm is received on the second layer covering the recess to formthe expandable accumulator.

According to one aspect, the device includes an actuator for pushing thediaphragm into the recess to reduce the volume of the accumulator.According to another aspect, the actuator comprises a rotatable cam.

According to another embodiment, a third layer is received against thediaphragm and has a bore aligned with the recess of the second layer,and the actuator comprises a piston slidingly received in the bore.According to one aspect, a magnetic coil is received in the third layercoaxial with the piston for biasing the piston against the diaphragmupon being electrified. According to another aspect, the dispenserincludes multiple accumulators arranged sequentially with respect to thepassageway, and magnetic coils and pistons associated with eachaccumulator.

According to another embodiment, a third layer is received against thediaphragm and has a bore aligned with the recess of the second layer,and a fourth layer is received against the third layer and has a borealigned with the bore of the third layer, and a gas generator isreceived in the bore of the fourth layer for pressurizing the bore andbiasing the piston against the diaphragm upon being actuated. Accordingto one aspect, the dispenser includes multiple accumulators arrangedsequentially with respect to the passageway, and gas generators andpistons associated with each accumulator.

According to a further embodiment, the dispenser includes a first layerhaving a surface defining a groove, with the diaphragm positionedagainst the surface of the first layer such that the diaphragm and thegroove define the passageway connected to the exit port assembly. Asecond layer is received against the diaphragm and includes a recessseparated from the passageway by the diaphragm, and the portion of thepassageway opposite the recess comprises the expandable accumulator. Anactuator is received in the recess of the second layer for pushing thediaphragm towards the first layer upon being actuated to reduce thevolume of the accumulator. According to one aspect, the actuatorcomprises a piece of piezoelectric material arranged to push thediaphragm upon contracting. According to another aspect, the actuatorcomprises multiple pieces of piezoelectric material arrangedsequentially with respect to the passageway within the recess.

Another embodiment includes a first layer received against a secondlayer, with the layers defining the passageway connected to the exitport assembly, and the second layer including a recess facing the firstlayer. The dispenser further includes a piston slidingly received in therecess of the second layer, such that the piston and the recess definethe expandable accumulator. According to one aspect, a spring biases thepiston towards the first layer. According to another aspect, a magneticcoil is received in the second layer coaxial with the piston for biasingthe piston towards the first layer upon being electrified.

These aspects of the invention together with additional features andadvantages thereof may best be understood by reference to the followingdetailed descriptions and examples taken in connection with theaccompanying illustrated drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first exemplary embodiment of a fluiddelivery device in accordance with this invention shown secured on apatient, and a remote control device for use with the fluid deliverydevice (the remote control device being enlarged with respect to thepatient and the fluid delivery device for purposes of illustration);

FIG. 2 is a sectional side view of the fluid delivery device of FIG. 1;

FIGS. 3 a and 3 b are sectional side views of a dispenser of the fluiddelivery device of FIG. 1, illustrating operation of the dispenser;

FIGS. 4 a and 4 b are sectional views of another dispenser constructedin accordance with the present invention, illustrating operation of thedispenser;

FIGS. 5 a and 5 b are sectional views of an additional dispenserconstructed in accordance with the present invention, illustratingoperation of the dispenser;

FIG. 6 is a sectional view of an additional embodiment of a dispenserconstructed in accordance with the present invention;

FIG. 7 is a top plan view of a portion of fluid delivery deviceconstructed in accordance with the present invention;

FIG. 8 is a sectional view of the portion of the fluid delivery devicetaken along line 8-8 of FIG. 7;

FIG. 9 is a sectional view of the portion of the fluid delivery devicetaken along line 9-9 of FIG. 7;

FIG. 10 is a sectional view of the portion of the fluid delivery devicetaken along line 10-10 of FIG. 7;

FIGS. 11 a and 11 b are sectional views of the entire fluid deliverydevice of FIG. 7, illustrating operation of the device;

FIGS. 12 a and 12 b are sectional views of an embodiment of a valveconstructed in accordance with the present disclosure, illustratingoperation of the valve;

FIGS. 13 a and 13 b are sectional views of another embodiment of a valveconstructed in accordance with the present disclosure, illustratingoperation of the valve;

FIG. 14 is a sectional view of a further embodiment of a valveconstructed in accordance with the present disclosure;

FIG. 15 is a sectional view of another embodiment of a valve constructedin accordance with the present disclosure;

FIG. 16 is a sectional view of another embodiment of a dispenserconstructed in accordance with the present invention;

FIGS. 17 a and 17 b are sectional views of another embodiment of adispenser constructed in accordance with the present disclosure,illustrating operation of the dispenser;

FIGS. 18 a and 18 b are sectional views of another embodiment of adispenser constructed in accordance with the present disclosure,illustrating operation of the dispenser;

FIGS. 19 a and 19 b are sectional views of another embodiment of adispenser constructed in accordance with the present disclosure,illustrating operation of the dispenser;

FIGS. 20 a and 20 b are sectional views of a further embodiment of adispenser constructed in accordance with the present disclosure,illustrating operation of the dispenser;

FIGS. 21 a, 21 b and 21 c are sectional views of another embodiment of adispenser constructed in accordance with the present disclosure,illustrating operation of the dispenser;

FIGS. 22 a and 22 b are sectional views of a portion of anotherembodiment of a fluid delivery device including a priming mechanismconstructed in accordance with the present disclosure, and illustratingoperation of the priming mechanism;

FIGS. 23 a and 23 b are sectional views of a portion of an additionalembodiment of a fluid delivery device including a priming mechanismconstructed in accordance with the present disclosure, and illustratingoperation of the priming mechanism;

FIG. 24 is a schematic illustration of a further embodiment of a fluiddelivery device constructed in accordance with the present disclosure;

FIG. 25 is a schematic illustration of another embodiment of a fluiddelivery device and a remote control device constructed in accordancewith the present disclosure;

FIG. 26 is a schematic illustration of an additional embodiment of afluid delivery device constructed in accordance with the presentdisclosure;

FIG. 27 is a schematic illustration of a further embodiment of a fluiddelivery device constructed in accordance with the present disclosure;

FIG. 28 is a schematic illustration of a further embodiment of a fluiddelivery device constructed in accordance with the present disclosure;

FIGS. 29 a through 29 d are sectional views of an embodiment of a fillport constructed in accordance with the present disclosure, andillustrating operation of the fill port;

FIGS. 30 a and 30 b are sectional views of another embodiment of a fillport constructed in accordance with the present disclosure, andillustrating operation of the fill port;

FIG. 31 is a top sectional view of another device constructed inaccordance with the present invention; and

FIG. 32 is a side elevation view, partially cut away, of the device ofFIG. 31.

Like reference characters designate identical or correspondingcomponents and units throughout the several views.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring first to FIGS. 1 and 2, there is illustrated a fluid deliverydevice 10 constructed in accordance with the present invention. Thetypes of liquids that can be delivered by the fluid delivery device ofthe present invention include, but are not limited to, insulin,antibiotics, nutritional fluids, total parenteral nutrition or TPN,analgesics, morphine, hormones or hormonal drugs, gene therapy drugs,anticoagulants, analgesics, cardiovascular medications, AZT orchemotherapeutics. The types of medical conditions that the fluiddelivery device of the present invention might be used to treat include,but are not limited to, diabetes, cardiovascular disease, pain, chronicpain, cancer, AIDS, neurological diseases, Alzheimer's Disease, ALS,Hepatitis, Parkinson's Disease or spasticity.

Referring to FIG. 2, the device 10 generally includes an exit portassembly 70 adapted to connect to a transcutaneous patient access toolsuch as a needle, a dispenser 40 for causing fluid from a reservoir 30to flow to the exit port assembly 70, and a processor or electronicmicrocontroller (hereinafter referred to as the “local” processor) 50connected to the dispenser 40.

The local processor 50 is programmed to cause a flow of fluid to theexit port assembly 70 based on flow instructions from a separate, remotecontrol device 100, an example of which is shown in FIG. 1. Referringalso to FIG. 2, the fluid delivery device 10 further includes a wirelessreceiver 60 connected to the local processor 50 for receiving the flowinstructions from the separate, remote control device 100 and deliveringthe flow instructions to the local processor. The device 10 alsoincludes a housing 20 containing the exit port assembly 70, thereservoir 30, the dispenser 40, the local processor 50, and the wirelessreceiver 60.

As shown, the housing 20 is free of user input components for providingflow instructions to the local processor 50, such as electromechanicalswitches or buttons on an outer surface 21 of the housing, or interfacesotherwise accessible to a user to adjust the programmed flow ratethrough the local processor 50. The lack of user input components allowsthe size, complexity and costs of the device 10 to be substantiallyreduced so that the device 10 lends itself to being small and disposablein nature.

In order to program, adjust the programming of, or otherwise communicateuser inputs to the local processor 50, the fluid delivery device 10includes the wireless communication element, or receiver 60 forreceiving the user inputs from the separate, remote control device 100of FIG. 1. Signals can be sent via a communication element (not shown)of the remote control device 100, which can include or be connected toan antenna 130, shown in FIG. 1 as being external to the device 100.

The remote control device 100 has user input components, including anarray of electromechanical switches, such as the membrane keypad 120shown. The control device 100 also includes user output components,including a visual display, such as a liquid crystal display (LCD) 110.Alternatively, the control device can be provided with a touch screenfor both user input and output. Although not shown in FIG. 1, the remotecontrol device 100 has its own processor (hereinafter referred to as the“remote” processor) connected to the membrane keypad 120 and the LCD110. The remote processor receives the user inputs from the membranekeypad 120 and provides “flow” instructions for transmission to thefluid delivery device 10, and provides information to the LCD 110. Sincethe remote control device 100 also includes a visual display 110, thefluid delivery device 10 can be void of an information screen, furtherreducing the size, complexity and costs of the device 10.

The communication element 60 of the device 10 preferably receiveselectronic communication from the remote control device 100 using radiofrequency or other wireless communication standards and protocols. In apreferred embodiment, the communication element 60 is a two-waycommunication element, including a receiver and a transmitter, forallowing the fluid delivery device 10 to send information back to theremote control device 100. In such an embodiment, the remote controldevice 100 also includes an integral communication element 60 comprisinga receiver and a transmitter, for allowing the remote control device 100to receive the information sent by the fluid delivery device 10.

The local processor 50 of the device 10 contains all the computerprograms and electronic circuitry needed to allow a user to program thedesired flow patterns and adjust the program as necessary. Suchcircuitry can include one or more microprocessors, digital and analogintegrated circuits, resistors, capacitors, transistors and othersemiconductors and other electronic components known to those skilled inthe art. The local processor 50 also includes programming, electroniccircuitry and memory to properly activate the dispenser 40 at the neededtime intervals.

In the exemplary embodiment of FIG. 2, the device 10 includes a powersupply 80, such as a battery or capacitor, for supplying power to thelocal processor 50. The power supply 80 is preferably integrated intothe fluid delivery device 10, but can be provided as replaceable, e.g.,a replaceable battery.

Although not shown, the device can include sensors or transducers suchas a reservoir volume transducer or a reservoir pressure transducer, fortransmitting information to the local processor 50 to indicate how andwhen to activate the dispenser 40, or to indicate other parametersdetermining flow, pump flowpath prime condition, blockage in flowpath,contact sensors, rotary motion or other motion indicators, as well asconditions such as the reservoir 30 being empty or leaking, or thedispensing of too much or too little fluid from the reservoir, etc.

The volume of the reservoir 30 is chosen to best suit the therapeuticapplication of the fluid delivery device 10 impacted by such factors asavailable concentrations of medicinal fluids to be delivered, acceptabletimes between refills or disposal of the fluid delivery device 10, sizeconstraints and other factors. The reservoir 30 may be prefilled by thedevice manufacturer or a cooperating drug manufacturer, or may includeexternal filling means, such as a fill port having needle insertionseptum or a Luer connector, for example. In addition, the device 10 canbe provided with a removable reservoir.

The exit port assembly 70 can include elements to penetrate the skin ofthe patient, or can be adapted to connect to a standard infusion devicethat includes transcutaneous delivery means. A needle connection tubingterminating in a skin penetrating cannula (not shown) can be provided asan integral part of the exit port assembly 70, for example, with theskin penetrating cannula comprising a rigid member, such as a needle.Alternatively, the exit port assembly 70 can be provided with a Luerconnector for connecting to a standard infusion device including a skinpenetrating cannula, such as a rigid needle. In the preferredembodiment, the exit port assembly 70 includes injection means, such asa spring driven mechanism, to assist in penetrating the skin with theskin penetrating cannula. If the cannula is a flexible tube, a rigidpenetrator within the lumen of the tube is driven through the skin bythe injection means, and withdrawn leaving the soft cannula in place,such as in the subcutaneous tissue of the patient or other internalsite. The injection means may be integral to the device 10, or removablesoon after transcutaneous penetration. In any event, the exit portassembly 70 can also be provided with a removable plug (not shown) forpreventing leakage during storage and shipment if pre-filled, and duringpriming if filled by user, and prior to use.

The device 10 can also be provided with an adhesive layer on the outersurface of the housing 20 for securing the device 10 directly to theskin of a patient, as shown in FIG. 1. Although not shown, the adhesivelayer is preferably provided in a continuous ring encircling the exitport assembly 70 in order to provide a protective seal around thepenetrated skin. The housing 20 can be made from flexible material, orcan be provided with flexible hinged sections that allow the fluiddelivery device 10 to flex during patient movement to prevent detachmentand aid in patient comfort.

The dispenser 40 is connected in fluid communication with the reservoir30, as shown in FIG. 2. When the device 10 is provided with apressurized reservoir 30 (i.e., fluid maintained within the reservoir ata pressure above atmospheric), the dispenser 40 can include an inletvalve 41 connected to the reservoir, an outlet valve 42 connected to theexit port assembly 70, and an accumulator 43 connected between the inletvalve and the outlet valve, as shown in the exemplary embodiment ofFIGS. 3 a and 3 b. Since the fluid in the reservoir 30 is maintained ata pressure above atmospheric pressure, opening of the inlet valve 41allows the accumulator 43 to fill to the reservoir pressure, after whichthe inlet valve is 41 is closed. At the proper time, as determined bythe local processor 50 programming and instructions received from theremote control device 100, the outlet valve 42 can be opened to dispensefluid to the exit port assembly 70, which is at the pressure of thepatient, or atmospheric pressure. The accumulator 43 will then be atatmospheric pressure, and the outlet valve 42 can be closed, ready foranother repeat cycle.

The dispenser 40 of the exemplary embodiment of FIGS. 3 a and 3 b doesnot create a driving or pumping force on the fluid passing therethrough,but rather acts as a metering device, allowing pulses of fluid to passfrom the pressurized reservoir 30, through the dispenser 40, to the exitport assembly 70 at atmospheric pressure. The inlet valve 41 and theoutlet valve 42 of the dispenser 40 are controlled by the localprocessor 50, which includes electronic programming, controls andcircuitry to allow sophisticated fluid delivery programming and controlof the dispenser 40.

FIG. 3 a shows the dispenser 40 with the accumulator 43 at atmosphericpressure. An accumulator membrane 44 is shown in a non-distended state,caused by atmospheric pressure only. Inlet valve 41 is closed, andoutlet valve 42 may be open or closed, but must have been opened sincethe last time inlet valve 41 was opened. FIG. 3 b shows the conditionwhere outlet valve 42 is closed, and inlet valve 41 has been opened.Because of the elevated pressure of the fluid from the reservoir 30, theaccumulator membrane 44 is distended, thus increasing the volume ofaccumulator 43 by an accumulator volume 45. After the inlet valve 41 isclosed, the outlet valve 42 can be opened, to dispense the accumulatorvolume 45 and allow the accumulator membrane 44 to retract to theposition shown in FIG. 3 a.

The inlet valve 41 and the outlet valve 42 of the dispenser 40 and thelocal processor 50 are designed to prevent both valves from being openedat the same time, precluding the reservoir 30 to ever flow directly tothe exit port assembly 70. The prevention of both valves opening at thesame time is critical and can be accomplished via mechanical means,electrical means, or both. The prevention can be accomplished in thedispenser 40 design, the local processor 50 design, or both.

The dispenser 40 shown in FIGS. 3 a and 3 b dispenses finite pulses offluid volume, called pulse volume (PV), with each activation. The PV isdetermined by the properties, materials and construction of theaccumulator 43 and the accumulator membrane 44. PV's delivered byinfusion devices are typically chosen to be small relative to what wouldbe considered a clinically significant volume. For insulin applicationsat a concentration of 100 units per ml, a PV of less than 2 microliter,and typically 0.5 microliter, is appropriate. If the fluid deliverydevice 10 is programmed via the remote control device 100 to deliver 2units an hour, the dispenser will deliver 40 pulses an hour, or a pulseevery 1.5 minutes. Such pulsitile flow is considered continuous if thePV is small enough. Other drugs or concentrations may permit a muchlarger PV. Various flow rates are achieved by adjusting the time betweenpulses. To give a fixed volume or bolus, multiple pulses are given inrapid succession until the bolus volume is reached.

The PV may not always be constant enough to be within the accuracyrequirements of the fluid delivery device 10. One factor impacting thePV is the pressure of the reservoir 30. The fluid delivery device 10 mayinclude means for monitoring reservoir 30 pressure and adjust the timingbetween pulses to achieve the desire flow pattern. An example of suchcompensation would be to decrease time between pulses as the reservoir30 pressure decreases to maintain the programmed flow rate. Analternative to monitoring reservoir 30 pressure is monitoring the volumeof the reservoir 30. Each time a pulse or series of pulses aredelivered, a measurement of reservoir 30 volume can indicate whether aproper amount of fluid has been delivered, both for individual pulsesand cumulative pulses. The system could also be designed to compensatefluid flow as errors are detected.

Referring now to FIGS. 4 a and 4 b, the present invention provides animproved dispenser 240 for use with the fluid delivery device 10 ofFIGS. 1 and 2. Operation of the dispenser 240 of FIGS. 4 a and 4 b issimilar to operation of the dispenser 40 of FIGS. 3 a and 3 b. Inaddition, some elements of the dispenser 240 of FIGS. 4 a and 4 b aresimilar to the dispenser 40 of FIGS. 3 a and 3 b such that similarelements have the same reference numeral preceded by a “2”.

The dispenser 240 of FIGS. 4 a and 4 b, however, includes at least twolaminated layers 252, 254 of material defining a passageway 250 forconnection to the exit port assembly 70, and an expandable accumulator243 in fluid communication with the passageway 250 for controlling fluidflow from the reservoir 30 to the exit port assembly 70. The laminatedconstruction provides many benefits including, but not limited to,simplifying the design and manufacturing of the dispenser 240, andfurther reducing the size, complexity and costs of the dispenser 240.The dispenser 240 of the present invention, therefore, lends itself tobeing small and disposable in nature.

In the embodiment of FIGS. 4 a and 4 b, the layers of the dispenser 240include a first layer 252 and a second layer 254 received against thefirst layer. At least one of the second and the first layers 252, 254includes a surface groove between the layers which defines thepassageway 250 connected to the exit port assembly 70. The second layer254 includes an opening 246 in fluid communication with the passageway250. The layers 252, 254 also include a resilient diaphragm 244 receivedon the second layer 254 covering the opening, and a third layer 256received over the diaphragm 244 on the second layer 254. The third layer256 has a pulse chamber 245 over the diaphragm 244 and in alignment withthe opening 246 of the second layer 254, and a relief port 247 in fluidcommunication with the pulse chamber 245.

FIG. 4 a shows the dispenser 240 with the accumulator 243 at atmosphericpressure with the resilient diaphragm 244 in a non-distended state.Inlet valve 241 is closed, and outlet valve 242 may be open or closed,but must have been opened since the last time the inlet valve 241 wasopened. FIG. 4 b shows the condition wherein the outlet valve 242 isclosed, and the inlet valve 241 has been opened. Because of the elevatedpressure of the fluid from the reservoir 30, the fluid expands theresilient diaphragm 244 into the pulse chamber 245 (with the relief port247 allowing evacuation of the pulse chamber 245), thus increasing thevolume of the accumulator 243 by about a volume of the pulse chamber245. After the inlet valve 241 is closed, the outlet valve 242 can beopened, to dispense the accumulator volume 245 and allow the resilientdiaphragm 244 to return to the position shown in FIG. 4 a.

The laminated construction of the dispenser 240 allows mostmanufacturing tolerances of the dispenser 240 to be lowered, and themanufacturing process to be simplified, without effecting theperformance and reliability of the dispenser 240. High tolerances arerequired for only the volume of the pulse chamber 245 and the resilienceof the diaphragm 244, since those dimensions affect the resulting PVproduced by the dispenser 240. Other dimensions and properties of thedispenser 240 can be relatively relaxed to reduce the costs of thedispenser. For example, in the embodiment shown, at least one of thesecond and the third layers 254, 256 defines a recess 260 receiving thediaphragm 244. The recess 260 has a depth about equal to a thickness ofthe diaphragm 244 such that the diaphragm is secured in a substantiallyfluid-tight manner between the second and the third layers 254, 256.However, a length and a width of the recess 260 are greater than alength and a width of the diaphragm 244 in order to decrease therequired manufacturing tolerances of the dispenser 240.

Manufacturing the dispenser 240 is preferably a “drop down” process.First the layers 252, 254, 256 are individually formed with thenecessary openings, groove, and recesses. The first layer 252 is thenlaid down and the valves 241, 242 are dropped into recesses (not shown)in the first layer and correctly positioned within the groove 250. Thenthe second layer 254 is placed on the first layer 252, and the diaphragm244 is placed in the recess 260 of the second layer. Finally, the thirdlayer 256 is positioned over the diaphragm 244 and the second layer 254.The layers 252, 254, 256 can be made from a suitably strong and rigidmaterial such as plastic or stainless steel, and can be secured togetherin a suitable manner, such as with adhesives or by welding. Thediaphragm 244 can be made from a suitably expandable yet resilientmaterial, such as rubber or a synthetic rubber.

Referring to FIGS. 5 a and 5 b, another dispenser 270 according to thepresent invention is shown. The dispenser 270 is similar to thedispenser 240 of FIGS. 4 a and 4 b such that similar elements have thesame reference numerals. A first layer 252 defines the passageway 250connected to the exit port assembly 70 and an opening 246 in fluidcommunication with the passageway. The resilient diaphragm 244 isreceived on the first layer 252 covering the opening 246, and a secondlayer 254 is received over the diaphragm 244 on the first layer. Thesecond layer 254 has a pulse chamber 245 over the diaphragm 244 and inalignment with the opening 246 of the first layer 252, and a relief port247 in fluid communication with the pulse chamber 245. A third layer 256is received on the second layer 254 and defines a relief chamber 248 influid communication with the relief port 247 of the second layer 252.The relief chamber 248 allows the pulse chamber 245 to be evacuated uponexpansion of the diaphragm 244, yet keeps the pulse chamber sealed andthe relief port protected. The relief chamber 248 can also bepressurized to further regulate the PV produced by the dispenser 270.

FIG. 6 shows another dispenser 280 according to the present invention.The dispenser 280 is similar to the dispenser 240 of FIGS. 4 a and 4 bsuch that similar elements have the same reference numerals. Thedispenser 280, however, further includes a compression spring 282biasing the diaphragm 244 away from the pulse chamber 245. The strengthof the spring is set along with the volume of the pulse chamber 245 andthe resilience of the diaphragm 244, to provide a predetermined PV.

FIGS. 7 through 11 a and 11 b show an entire fluid delivery device 290incorporating the laminated construction provided by the presentinvention. The device 290 is similar to the device of FIGS. 1 and 2, butincludes a first layer 252 and a resilient diaphragm 288 received on asurface of the first layer. The surface of the layer 252 has a recessand a groove extending from the recess to the exit port assembly 70,such that the recess of the layer 252 and a portion 244 of the diaphragm288 define the expandable accumulator 243, and the groove of the layer252 and the diaphragm 288 define the passageway 250 connected to theexit port assembly 70.

As shown best on FIG. 7, the surface of the first layer 252 also has avalve seat 292 in the groove and an occlusion sensor recess 294 in thegroove, between the valve seat 292 and the exit port assembly 70. Thesurface of the first layer 252 further includes a reservoir recess 296,a groove 298 extending between the reservoir and the accumulator 243,and a valve seat 291 in the groove 298. In addition, the surface of thefirst layer 252 includes a bubble removal bay 300, a groove 302extending between the bubble removal bay 300 and the reservoir recess296, a fill port recess 304, and a groove 298 extending between the fillport recess 304 and the bubble removal bay 300.

As also shown in FIGS. 8 through 11 a and 11 b, the diaphragm 288 andthe first layer 252, therefore, define an occlusion sensor chamber 294,the reservoir 296, a bubble removal chamber 300, and connectingpassageways 298, 302, 306. In between the recesses and grooves, thediaphragm 288 is secured to the surface of the layer 252 in afluid-tight manner, such as with an adhesive. As best shown in FIGS. 8through 10, the portion 244 of the diaphragm 288 expands when thereservoir 296 is filled in order to pressurize the fluid within thereservoir. In addition, upon the incidence of an occlusion, fluid backsup in the occlusion sensor chamber 294 and causes the portion of thediaphragm 288 over the chamber 294 to expand and increase pressurewithin the chamber. A switch 308 is positioned in the chamber 294 tomonitor for an occlusion, as shown in FIG. 9. The switch 308 is arrangedsuch that when that portion of the diaphragm 288 over the chamber 294expands, the switch closes to indicate an occlusion. Alternatively, astrain gage can be attached to that portion of the diaphragm 288 overthe chamber 294, or a pressure sensor can be positioned in the chamber294 to monitor for an occlusion.

The diaphragm 288 can be provided with consistent properties, such asresilience, throughout, or can include inconsistent properties. Forexample, the portion 244 of the diaphragm 288 over the reservoir recess296 can be provided with a greater thickness to increase the resilienceof that portion, while the thickness of the diaphragm 288 over the valveseats 291, 292 may be made thinner to decrease the resilience of thoseportions. In addition, the diaphragm 288 can be made from a materialthat allows gas to pass through yet prevents liquid from passingthrough, such that the diaphragm 288 also acts as a bubble removalfilter. Furthermore, the diaphragm 288 can be provided with coatings.For example, surfaces of the diaphragm 288 in contact with flow pathscan be coated with material that promotes flow and avoids precipitation(such as insulin crystallization). The diaphragm 288 can also be coatedwith lines of conductive material, for example, to support transmissionof electrical signals between the local processor and other componentsof the device.

As shown in FIG. 7, the first layer 252 also defines recesses 310, 312,314, which are not covered by the diaphragm 288, for other components ofthe device including the local processor 50, the wireless communicationunit 60 and the battery 80. FIGS. 11 a and 11 b show a cover 316attached to the first layer 252 to complete the housing 20 of the fluiddeliver device 290. The cover 316 contains the power source 80, thewireless communication unit 60 and the local processor 50 of the device290. The cover 316 also includes the inlet and the outlet valves 241,242 aligned over the valve seats 291, 292 of the first layer 252. Thevalves 241, 242 and the accumulator 243 comprise the dispenser 320 foruse with the pressurized reservoir 296. As shown, the cover 316 alsoprovides an enclosed space that allows for expansion of the diaphragmportion 244 over the reservoir 296.

FIGS. 12 a and 12 b show a valve 330 constructed in accordance with thepresent invention for use as part of a laminated dispenser or part of alaminated fluid delivery device. The valve 330, for example, cancomprise the inlet valve of the dispenser controlling flow from areservoir into the accumulator. The valve 330 is part of a passageway250 formed from first and second layers 252, 254, wherein the secondlayer 254 includes an opening 332 communicating with the passageway. Thevalve 330 includes a layer of resilient fluid-tight material 334covering the opening, and a layer of piezoelectric material 336 coveringthe layer of resilient fluid-tight material.

The layers of resilient fluid-tight material 334 and piezoelectricmaterial 336 are arranged such that upon contracting, the layer ofpiezoelectric material 336 forces the layer of resilient fluid-tightmaterial 334 into the opening 332 of the passageway 250 andsubstantially closes the passageway, as shown in FIG. 12 a. As shown,the piezoelectric material 336 includes a wire 338 for connection to apower source (not shown). When power is applied to the piezoelectricmaterial 336, the piezoelectric material straightens out, therebyopening the passageway 250, as shown in FIG. 12 b. The resilientfluid-tight material 334 can be provided as part of the resilientdiaphragm forming the accumulator of the dispenser. In the preferredembodiment, the piezoelectric material 336 is normally curved whende-energized, and deforms to a straight geometry when energized, suchthat the passageway 250 is normally closed.

FIGS. 13 a and 13 b show another valve 340 constructed in accordancewith the present invention. The valve 340 is similar to the valve 330 ofFIGS. 12 a and 12 b such that similar elements have the same referencenumerals. The valve 340 of FIGS. 13 a and 13 b, however, furtherincludes an opening 332 in the first layer 252, and a layer of resilientfluid-tight material 334 covering the opening in the first layer, and alayer of piezoelectric material 336 covering the layer of resilientfluid-tight material. As shown, the layers of piezoelectric material 336react together to close the passageway 250 when de-energized (FIG. 13a), and to open the passageway when energized (FIG. 13 b). Analternative embodiment can include a tubular layer of resilientfluid-tight material and a tubular layer of piezoelectric materialpositioned over an annular opening in the passageway.

A valve assembly 350 constructed in accordance with the presentinvention is shown in FIG. 14. The valve assembly 350 is shown as partof a laminated dispenser having first, second and third layers 252, 254,256. The first layer 252 defines the pulse chamber 245, the evacuationport 247, and the enlarged recess 260 receiving the diaphragm 244 overthe pulse chamber to form the accumulator 243. The second layer 254defines the groove for the passageway 250, an opening 246 communicatingwith the groove in alignment with the pulse chamber 245, and a recess351 on the surface of the second layer 254 in alignment with theopening. The third layer 256 defines a valve assembly chamber 352 facingthe second layer 254 in alignment with the recess 351 of the secondlayer.

The valve assembly 350 includes a valve member 354, springs 356 and afluid resistant cover 358. The valve member 354 is received in the valveassembly chamber 352 of the third layer 256 and includes a bar 360extending parallel with the passageway 250 and pivotally mounted on thethird layer about a pivot point 364 aligned with the accumulator 243. Aninlet valve 361 and an outlet valve 362 extend from the bar 360 into thepassageway 250 on opposite sides of the pivot point 364 (and on oppositesides of the accumulator 243). The springs 356 are positioned betweenthe ends of the bar 360 and the third layer 256 to bias each end towardsthe second layer 254. The fluid resistant cover 358 is received in therecess 351 of the second layer 254 (the recess preferably beingoversized with respect to the cover to reduce manufacturing tolerances),and provides a water-tight seal between the passageway 250 and the valveassembly 350.

Although not shown, the valve assembly 350 also includes an actuator forcausing the valve member 354 to pivot. The actuator can comprise arotary motor, a linear motor, a clock spring, and piezoelectricmaterial, for example. Many different types of actuators can be used forcausing the valve member 354 to pivot when desired. The pivoting valveassembly 354 provides the benefit of the valves 361, 362 alternativelyblocking the passageway 250 at all times, such that unregulated flow tothe exit port assembly is not permitted. As shown in FIG. 14, the valveassembly 350 also utilizes “drop down” construction, wherein allelements of the valve assembly are assembled from above the second layer254, to simplify manufacturing.

Another valve assembly 370 constructed in accordance with the presentinvention is shown in FIG. 15. The valve assembly 370 is shown as partof a laminated dispenser having first and second layers 252, 254, withthe passageway 250 defined between the layers. The laminated layers 252,254 also define a bore 372 bisecting the passageway 250 and receivingthe valve assembly 370.

The valve assembly 370 includes a valve member 374 movably received inthe bore 372 and including an opening 376, and a spring 378 biasing thevalve member such that the opening 376 of the valve member is normallyoffset from the passageway 250 and the passageway is blocked by thevalve member 374. The assembly 370 also includes an actuator 380 formoving the valve member 374 upon being actuated such that the opening376 of the valve member 374 aligns with the passageway 250 to therebyallow flow through the passageway. In the embodiment shown, the actuatorcomprises a gas generator 380 for pressurizing the bore 372 upon beingactuated. The gas generator 380 is mounted in a plug 382 fitted in thesecond layer 254 and having a gas release port 384 communicating withthe bore 372. As shown in FIG. 15, the valve assembly 370 also utilizes“drop down” construction, wherein all elements of the valve assembly canbe assembled from above the second layer 254, to simplify manufacturing.

During operation, the actuated gas generator 380 pressurizes the bore372 above the valve member 374 and forces the valve member to moveagainst the spring 378, so that the opening 376 aligns with thepassageway 250 and opens the passageway. The gas release port 384 allowsa predetermined rate of gas to exit the bore 372 in order to limit thetotal pressure in the bore and allow a controlled decay of pressure. Inone embodiment, the valve assembly 370 is positioned near the exit portassembly of a fluid delivery device to limit the useable life of thefluid delivery device. For example, the fluid delivery device caninclude automatic or manual means for actuating the gas generator 380upon the device being secured to a patient's skin, and the gas generatorcan be provided with enough fuel to maintain the valve member 374 openfor three days. When the fuel in the gas generator 380 is depleted, thevalve member 374 closes and the fluid delivery device must be replacedwith a new device. The valve 370 can also be used to pulse fluid as longas the gas generation rate of the gas generator 380 and the gas releaserate of the gas release port 384 have time constants slightly smallerthan the maximum pulse rate.

Referring now to FIG. 16, another laminated dispenser 390 constructed inaccordance with the present invention is shown. The dispenser 390 is foruse with a pressurized reservoir and includes an inlet valve 241, anaccumulator 243 and an outlet valve 242. The dispenser includes threelayers 252, 254, 256. The second and the first layers 252, 254 definethe passageway 250 connected to the exit port assembly, and the secondlayer 254 defines the pulse chamber 245 communicating with thepassageway.

A piston 392 is slidingly received in the pulse chamber 245, and asubstantially fluid tight seal is provided between the piston and thewall of the pulse chamber. The piston 392 in effect comprises theexpandable membrane of the accumulator 243. The third layer 256 isreceived on the second layer 254 and closes the pulse chamber 245, andsprings 394 are positioned between the third layer and the piston 392and bias the piston away from the third layer. During operation, theoutlet valve 242 is closed and the inlet valve 241 is opened to allowpressurized fluid from the reservoir to move the piston 392 against thesprings 392 and into the pulse chamber 245 to expand the accumulator 243by the predetermined pulse volume. Then the inlet valve 241 is closedand the outlet valve 242 is opened such that the biased piston 392 canforce the pulse volume of liquid to the exit port assembly.

Referring to FIGS. 17 a and 17 b, an additional laminated dispenser 400constructed in accordance with the present invention is shown. Thedispenser 400 is for use with a non-pressurized reservoir (not shown)and, therefore, is designed to act as a pump instead of simply aregulator. The dispenser 400 includes an inlet valve 402, an accumulator404, and an outlet valve 406. The valves 402, 406 comprise one-wayvalves, such as duckbill valves, and the accumulator 404 is an “active”accumulator, as opposed to the “passive” accumulators used in thepreviously described dispensers.

The second and the first layers 252, 254 of the dispenser 400 define thepassageway 250 connected between the reservoir and the exit portassembly, and the second layer 254 defines a bore 408 communicating withthe passageway 250. A piston 410 is slidingly received in the bore 408and acts as the expandable membrane of the accumulator 404. Thedispenser 400 also includes an actuator 412 for moving the piston 410 inthe bore 408 to draw fluid from the reservoir through the inlet valve402 (the one-way outlet valve 406 prevents fluid from being draw thoughthe outlet valve 406) and expel liquid through the outlet valve 406 tothe exit port assembly (the one-way inlet valve 402 prevents fluid frombeing expelled though the inlet valve 402).

In the embodiment show, the actuator comprises a magnetic coil 412received in an annular groove provided in the second layer 254, coaxialwith the piston 410, which is made from magnetic material. A plug 414seals the piston 410 and the coil 412 in the second layer 254, such thatthe portion of the bore 408 between the piston 410 and the plug 414comprises the pulse chamber of the accumulator 404. The dispenser 400includes a coiled compression spring 416 positioned between the plug 414and the piston 410 biasing the piston towards the passageway 250. Thecoil 412 is arranged to bias the piston 410 against the spring 416 uponbeing energized.

During operation of the dispenser 400, the coil 412 is energized suchthat movement of the piston 410 expands the accumulator 404, and drawsfluid from the reservoir, through the one-way inlet valve 402 and intothe bore 408, as shown in FIG. 17 a. The one-way inlet valve 402 closeswhen the accumulator 404 is fully expanded. Then the coil 412 isde-energized, so that the spring 416 is allowed to push the piston 410back towards the passageway 250, compress the accumulator 404, and expelthe liquid through the one-way outlet valve 406 to the exit portassembly, as shown in FIG. 17 b.

FIGS. 18 a and 18 b, show another laminated dispenser 420 constructed inaccordance with the present invention, and which operates in a mannersimilar to the dispenser 400 of FIGS. 17 a and 17 b. The dispenser 420includes a one-way inlet valve 402, an “active” accumulator 424, and aone-way outlet valve 406. The second and the first layers 252, 254 ofthe dispenser 420 define the passageway 250 connected between thereservoir (not shown) and the exit port assembly (not shown).

The accumulator 424 includes a pulse chamber 426 formed in a surface ofthe second layer 254 facing away from the first layer 252, and anopening 428 providing fluid communication between the pulse chamber 426and the passageway 250. A resilient diaphragm 430 is received on thesecond layer 254 and covering the pulse chamber 426 in a fluid-tightmanner.

The dispenser 420 also includes an actuator 432 for pushing thediaphragm 430 into the pulse chamber 426 to reduce the volume of theaccumulator 424 and produce a pulse volume. In the embodiment shown, theactuator comprises a rotatable cam 432 and a motor (not shown) or otherrotational device for rotating the cam. During operation, the cam 432 isrotated away from the diaphragm 430 such that the diaphragm expands theaccumulator 424, and draws fluid from the reservoir, through the inletvalve 402 and into the pulse chamber 426, as shown in FIG. 18 a. Theinlet valve 402 closes when the accumulator 424 is fully expanded. Thenthe cam 432 is rotated back into the diaphragm 430, so that thediaphragm compresses the pulse chamber 426 and expels the liquid throughthe outlet valve 406 to the exit port assembly, as shown in FIG. 18 b.

Referring to FIGS. 19 a and 19 b, an additional laminated dispenser 440constructed in accordance with the present invention is shown. Thedispenser 440 is for use with a non-pressurized reservoir (not shown)and, therefore, is designed to act as a pump instead of simply aregulator. The dispenser 440 includes a plurality of “active”accumulators 442 and no inlet valve or outlet valve. The accumulators442 are arranged successively with respect to the passageway 250 andoperate one after another such that the dispenser 440 operates as alinear peristaltic pump.

The second and the first layers 252, 254 of the dispenser 440 define thepassageway 250 connected between the reservoir and the exit portassembly. The resilient diaphragm 444 is positioned between the secondlayer 254 and the third layer 256 in a liquid-tight manner. For eachaccumulator 442, the second layer 254 defines a pulse chamber 446communicating with the passageway 250, and the third layer 256 defines abore 448 aligned with the pulse chamber.

The dispenser 440 also includes actuators for compressing the pulsechambers 446 and expelling pulse volumes of liquid towards the exit portassembly. In the embodiment shown, the actuators comprise pistons 450made from magnetic material and slidingly received in the bores 448, andmagnetic coils 452 received in annular grooves provided in the thirdlayer 256, coaxial with the pistons 450. Each coil 452 is arranged suchthat, upon being energized, the coil 452 forces the piston 450 againstthe diaphragm 444 to collapse the pulse chamber 446 and expel a pulsevolume of fluid from the accumulator 442 into the passageway 250. Uponbeing de-energized, the coil 452 releases the piston 450 and allows thediaphragm 444 to push the piston back, and draw a pulse volume of fluidinto the pulse chamber 446. During operation of the dispenser 440, thecoils 452 are successively energized and de-energized so that fluid isdrawn from the reservoir, expelled and drawn successively into theaccumulators 442, and expelled to the exit port assembly. Preferably, atleast one of the pistons 450 is always in a closed position to occludethe fluid path and prevent the free flow of fluid through the passagewayto the exit port assembly. In an alternative embodiment, the pistons 450can be biased closed, with a spring, and the coils 452 arranged to pullthe pistons away from the passageway when energized.

FIGS. 20 a and 20 b show another laminated dispenser 460 according tothe present invention. The dispenser 460 is similar to the dispenser 440of FIGS. 19 a and 19 b, but includes a fourth layer 258 defining bores462 aligned with the bores 448 of the third layer 256. In addition, theactuators comprise the pistons 450, and gas generators 464 received inthe bores 462 of the fourth layer 258. The gas generators 464 pressurizethe bores 448, 462 and biasing the piston 450 against the diaphragm 444upon being actuated. The fourth layer 258 also includes gas releaseports 466 communicating with the bores 462.

Referring to FIGS. 21 a, 21 b, and 21 c, a further embodiment of alaminated dispenser 470 constructed in accordance with the presentinvention is shown. The dispenser 470 is also for use with anon-pressurized reservoir and acts as a pump instead of simply aregulator. The dispenser 470 includes a plurality of “active”accumulators 472 and no inlet valve or outlet valve. The accumulators472 are arranged successively with respect to the passageway 250 andoperate one after another such that the dispenser 470 operates as alinear peristaltic pump.

The dispenser 470 includes a first layer 252 having a recess 476, with adiaphragm 474 positioned against the surface of the first layer 252. Thesecond layer 254 is received against the diaphragm 474 and includes asurface defining a groove, such that the diaphragm and the groove definethe passageway 250 connecting the reservoir to the exit port assembly.

Each accumulator 472 includes an actuator 478. The actuators 478 aresuccessively positioned with respect to the passageway 250 within therecess 476 of the first layer 252. The actuators 478 are arranged topush the diaphragm 474 towards the second layer 254 upon being actuated.The portion of the recess 476 above the diaphragm 474 comprises thepulse chambers of the accumulators 472.

In the embodiment shown, the actuators comprise segments ofpiezoelectric material 478. Each segment 478 is mounted and arrangedsuch that, when de-energized, the segment 478 normally assumes a curvedgeometry to push the diaphragm 474 towards the second layer, and whenenergized, deforms to a straight geometry to allow the diaphragm toreturn to its original position. In the preferred embodiment all of thepiezoelectric elements 478 are normally in a curved state whende-energized, to occlude the passageway 250 and prevent the free flow offluid through the passageway to the exit port assembly.

Referring now to FIGS. 22 a and 22 b, the present invention alsoprovides a priming mechanism 500 for simultaneously maintaining an inletvalve 502 and an outlet valve 504 of a dispenser 506 open, such thatfluid can flow through the dispenser (also having an accumulator 507) tothe exit port assembly 70 during filling of the reservoir 30. Primingensures that the entire volume of the fluid delivery passages of thefluid delivery device are filled with fluid prior to operation, so thatan accurate volume of fluid can be delivered by the device.

In the specific embodiment shown, the priming mechanism 500 includes apivotally movable first link 508 operatively connected to the inletvalve 502 such that the inlet valve is opened upon pivoting movement ofthe first link 508. A pivotally movable second link 510 is operativelyconnected to the outlet valve 504 such that the outlet valve is openedupon pivoting movement of the second link. The priming mechanism 500also includes a movable priming rod 516 operatively connected to thefirst and the second links 508, 510 for pivoting the links upon movementof the rod 516.

As shown, the inlet and the outlet valves 502, 504 each include a valvemember 512, 514 movable between open and closed positions. The firstlink 508 extends between the first valve member 512 and the priming rod516 and is pivotally movable about a pivot point 518 of the first linklocated between the valve member 512 and the priming rod. The secondlink 510 extends between the second valve member 514 and the priming rod516 and is pivotally movable about a pivot point 520 of the second linklocated between the valve member 514 and the priming rod. The primingrod 516 is linearly movable to pivot the links 508, 510 and open thevalve members 512, 514. The priming rod 516 extends out of the housing20 of the fluid delivery device, and is depressed into the housing 20 bya user to open the valves 502, 504 prior to filling the reservoir 30through fill port 522. One-way valves, such as duckbill valves 524, arepositioned within the fill port 522 and a passageway 526 of thedispenser 506. FIG. 22 b shows the priming rod 516 depressed into thehousing 20 and the valves 502, 504 opened, while FIG. 22 a shows thepriming rod 516 extending out of the housing 20 and the valves 502, 504closed.

FIGS. 23 a and 23 b shown another priming mechanism 530 according to thepresent invention. The mechanism 530 is similar to the mechanism 500 ofFIGS. 22 a and 22 b such that similar elements have the same referencenumerals. The mechanism 530, however, further includes a collar 532connected to the priming rod 516 and received in the fill port 522 ofthe device. The fill port 522 is connected to the reservoir 30 andadapted for receiving a needle 534 for filling the reservoir. The collar532 is adapted to frictionally receive the needle 534 inserted into thefill port 522 so that the inserted needle causes movement of the collar532 and the priming rod 516 and pivoting movement of the links 508, 510.The dispenser valves 502, 504 are therefore opened and the device isprimed automatically upon filling of the reservoir 30, shown in FIG. 23b.

Referring to FIGS. 24 to 26, the present invention also provides fluiddelivery devices 10 having automatic priming systems 600, 610, 620. Eachdevice 10 is provided with an exit port assembly comprising anintegrated transcutaneous patient access tool 670 having a knowninternal volume. In the particular embodiments shown, the patient accesstool is a needle 670. Because the volume to the tip of the needle 670 isknown, the local processor 50 of the device 10 can be programmed toprime the needle 670 automatically.

In the preferred embodiment of FIG. 24, the local processor 50 isprogrammed to instruct the dispenser 40 to deliver a volume of fluid tothe needle 670 equal to the known internal volume of the needle 670.Preferably, the remote controller 100 is provided with a “PRIME” commandfor a user to select. In the embodiment of the controller 100illustrated in FIG. 24, a prime command button 111 is shown provided ona touch screen 110 after an “INITIALIZE” command 112. When the primecommand 111 is selected, the remote controller 100 communicates with thefluid delivery device 10 and instructs the local processor 50 to primethe needle 670.

The fluid delivery device 610 of FIG. 25 further includes a flow sensor612 arranged to provide a signal to the local processor 50 indicative ofthe volume of fluid passing from the dispenser 40 to the needle 670. Thelocal processor 50 is programmed to prime the needle 670 by instructingthe dispenser 40 to deliver fluid until the flow sensor 612 indicates tothe local processor that a volume of fluid equal to the known internalvolume of the needle 670 has been delivered to the needle. The localprocessor 50 is also programmed to utilize the signals from the flowsensor 612 to monitor the needle 670 for occlusions once the needle hasbeen primed.

The device 620 of FIG. 26 is similar to the device 600 of FIG. 24, butfurther includes a fluid detector 622 positioned between the dispenser40 and the needle 670 for providing a signal to the local processor 50indicative of fluid passing into the needle 670. The local processor 50is programmed to prime the needle 670 by instructing the dispenser 40 todeliver fluid for a predetermined period and at a predetermined flowrate after receiving an initial indication from the fluid detector 622that fluid has reached the fluid detector 622. In addition, the localprocessor 50 can be programmed to provide a signal that air has beendetected in the fluid path when the fluid detector 622 stops indicatingthe presence of fluid upon operation of the dispenser 40 and after theneedle 670 has been primed.

Referring now to FIGS. 27 and 28, the invention also providesembodiments 700, 710 of the fluid delivery device including gas removalfilters 702 for removing gas (e.g., air) bubbles from fluid injectedinto the devices from a patient. In general the gas removal filters 702are constructed of material that allows the passage of gas therethrough,yet prevents fluid from passing therethrough. Gas removal filters areavailable, for example, from Pall Corporation of East Hills, N.Y.(www.pall.com). In the embodiment 700 of FIG. 27, the gas removal filter702 is positioned between the reservoir 30 and the dispenser 40. In theembodiment 720 of FIG. 28, however, the gas removal filter 702 ispositioned between a fill port 31 and the reservoir 30. Otherembodiments are possible. For example, the device can be provided with areservoir made from gas removal material instead of having a separategas removal filter.

Due to issues of infection and contamination, it may be desirable tolimit the fluid delivery device of the present invention to a singleuse. Referring to FIGS. 29 a through 29 d, the present invention,therefore, also provides a “single-use” fill port 800 for allowing thereservoir 30 of the fluid device to be filled only once. The fill port800 includes a passageway 802 in fluid communication with the reservoir30, a valve 804 positioned within the passageway and allowing one-wayflow into the reservoir 30, and a removable needle insertion septum 806sealing the passageway 802. The needle insertion septum 806 may beconstructed of a resealing elastomer such as silicone that allows aneedle 150 to puncture the septum 806 to add fluid to the reservoir 30,yet provides a seal around the needle 150.

In the embodiment of FIGS. 29 a through 29 b, the fill port 800 includesa funnel 808 having a small open end 810 removably received in thepassageway 802 and a large open end 812 receiving the septum 806. Thefill port 800 also includes a first wall 814 having an opening 816removably receiving the large open end 812 of the funnel when the smallopen end 810 of the funnel 808 is removably received in the passageway802, as shown in FIGS. 29 a and 29 b. A second wall 818 is spaced fromthe first wall 814 more than a thickness of the septum 806 and has anopening 820 sized to allow passage of a needle 150, but prevent passageof the septum 806, as shown in FIGS. 29 c and 29 d. As shown in FIGS. 29c and 29 d, removal of the needle 150 from the fill port 800 pulls thefunnel 808 out of the passageway 802, and thus prevents further refillsof the reservoir 30 through the fill port 800.

FIGS. 30 a and 30 b show another fill port 850 constructed in accordancewith the present invention. The fill port 850 includes a first wall 852having an opening 854 preventing passage of the septum 806, as shown inFIG. 30 a, and a second wall 856 spaced from the first wall 852 at leastabout a thickness of the septum and having an opening 858 allowingpassage of a needle 150. The second wall 856 and the opening of thesecond wall 858 are adapted to allow passage of the septum 806 upon atleast a predetermined force applied to the septum. Preferably, thepredetermined force is less than a force required to pull a needle 150out of the septum 806, such that a withdrawn needle 150 pulls the septum806 out of the fill port 850, as shown in FIG. 30 b.

Referring to FIG. 31, the present invention also provides a fluiddelivery device 900 having multiple subcutaneous access tools 970. Eachaccess tool 970 is independently connected to the dispenser 40 through apassageway 972, and is initially retracted such that the passageway 972is occluded. Each access tool 970 is also independently deployable. Upondeployment of each access tool 970, the passageway 972 of the deployedtool is released to allow fluid flow through the deployed tool.Preferably each access tool includes a rigid needle 974, as shown inFIG. 32.

The multiple, independently deployable needles 974 beneficially extendthe useful life of the fluid delivery device 900. According to standardsset by the Center for Disease Control (CDC), a single needle, such as aninfusion needle or intravenous needle, should not remain deployed in apatient for more than three days, to minimize the chances for infectionat the injection site through the skin of the patient. The presentinvention, therefore, increases the useable life of a single fluiddelivery device 900 by providing the device with multiple, independentlydeployable needles 974. If the device is provided with three retractableneedles 974, and each needle is used for the maximum allowable period ofthree days in accordance to CDC standards, for example, the life of thedevice 900 can be extended to nine days. The embodiment 900 of FIG. 31is provided with three needles 974, but can be provided with two needlesor more than three needles, as desired and appropriate.

Referring to the specific embodiment 900 as shown in FIG. 32, eachneedle 974 is manually deployable and includes a slidable lever 976secured to the needle and extending out of the housing 20 of the devicefor patient access. The needle 974 is shown retracted in FIG. 32, withthe passageway 972 occluded by an occlusion member 978 extending fromthe lever 976 and pinching the passageway 972 against a boss 980extending from the housing wall 20. When the device 900 is attached to askin surface of a patient, the patient simply slides the lever 976towards the skin to release the passageway 972 and inject the needle 974into the skin. After three days, the patient slides the lever 976 awayfrom the skin to withdraw the needle 974 from the skin and occlude thepassageway 972. The next needle can then be deployed. The device canalso be provided with means for maintaining each of the needles 974 inan independent sterile condition prior to deployment, such as separatesealed membranes covering the needle opening in the housing 20 and thatthe needles puncture through during deployment.

Although exemplary embodiments of the invention have been shown anddescribed, many changes, modifications and substitutions may be made bythose having ordinary skill in the art without necessarily departingfrom the spirit and scope of this invention.

1. A device for delivering fluid to a patient, comprising: A) areservoir; B) an exit port assembly adapted to connect to atranscutaneous patient access tool; and C) a dispenser including atleast two laminated layers of material defining a passageway connectingthe reservoir to the exit port assembly, and an expandable accumulatorin fluid communication with the passageway.
 2. A device according toclaim 1, wherein at least one layer of the dispenser comprises aresilient diaphragm.
 3. A device according to claim 2, wherein the atleast two laminated layers of the dispenser further comprise: a firstlayer; a second layer received against the first layer, the second andthe first layers including at least one groove defining the passagewayconnected to the exit port assembly, the second layer including anopening in fluid communication with the passageway, and wherein theresilient diaphragm is received on the second layer covering theopening; and a third layer received over the diaphragm on the secondlayer, the third layer having an pulse chamber over the diaphragm and inalignment with the opening of the second layer, and a port in fluidcommunication with the pulse chamber.
 4. A device according to claim 3,wherein the pulse chamber has a predetermined volume.
 5. A deviceaccording to claim 3, wherein one of the second and the third layersdefines a recess receiving the diaphragm, and wherein the recess has adepth about equal to a thickness of the diaphragm such that thediaphragm is secured in a substantially fluid-tight manner between thesecond and the third layers.
 6. A device according to claim 5, wherein alength and a width of the recess are greater than a length and a widthof the diaphragm.
 7. A device according to claim 2, wherein the at leasttwo laminated layers of the dispenser further comprise: a first layerdefining the passageway connected to the exit port assembly and anopening in fluid communication with the passageway, and wherein theresilient diaphragm is received on the first layer covering the opening;a second layer received over the diaphragm on the first layer, thesecond layer having an pulse chamber over the diaphragm and in alignmentwith the opening of the first layer, and a port in fluid communicationwith the pulse chamber; and a third layer received on the second layerand defining a secondary chamber in fluid communication with the port ofthe second layer.
 8. A device according to claim 3, further comprising aspring biasing the diaphragm away from the pulse chamber.
 9. A deviceaccording to claim 2, wherein the at least two laminated layers of thedispenser further comprise: a first layer having a surface defining arecess and a groove extending from the recess; wherein the resilientdiaphragm is received on the surface of the first layer such that therecess and the diaphragm define the expandable accumulator and thegroove and the diaphragm defines the passageway connected to the exitport assembly.
 10. A device according to claim 7, wherein the surface ofthe first layer further defines a valve seat in the groove. 11.(Canceled)
 12. (Canceled)
 13. (Canceled)
 14. A device according to claim2, wherein the at least two laminated layers of the dispenser furthercomprise: a first layer; and a second layer received against the firstlayer, at least one the second and the first layers having a groovedefining the passageway connected to the exit port assembly, the secondlayer including a surface facing away from the first layer and having arecess, and an opening providing fluid communication between the recessand the passageway; wherein the resilient diaphragm is received on thesecond layer covering the recess to form the expandable accumulator. 15.A device according to claim 14, further comprising an actuator forpushing the diaphragm into the recess to reduce the volume of theaccumulator.
 16. A device according to claim 15, wherein the actuatorcomprises a rotatable cam.
 17. A device according to claim 14, furthercomprising: a third layer received against the diaphragm and on thesecond layer and having a bore aligned with the recess of the secondlayer; and wherein the actuator comprises a piston slidingly received inthe bore.
 18. A device according to claim 17, further comprising amagnetic coil received in the third layer coaxial with the piston forbiasing the piston against the diaphragm upon being energized.
 19. Adevice according to claim 17, further comprising: a fourth layerreceived against the third layer and having a bore aligned with the boreof the third layer; and wherein the dispenser includes a gas generatorreceived in the bore of the fourth layer for pressurizing the bore andbiasing the piston against the diaphragm upon being actuated.
 20. Adevice according to claim 17, comprising multiple accumulators arrangedsequentially with respect to the passageway.
 21. A device according toclaim 2, wherein the at least two laminated layers of the dispenserfurther comprise: first and second layers wherein the diaphragm ispositioned between the layers, and one of the layers has a groovedefining the passageway connected to the exit port assembly, and theother of the layers has a recess separated from the passageway by thediaphragm; and the dispenser further includes an actuator received inthe recess for pushing the diaphragm into the passageway upon beingactuated.
 22. A device according to claim 21, wherein the actuatorcomprises a piece of piezoelectric material arranged to push thediaphragm upon the piezoelectric material assuming one of a deformedstate and an undeformed state.
 23. A device according to claim 22,comprising multiple pieces of piezoelectric material arrangedsequentially with respect to the passageway.
 24. A device according toclaim 1, wherein the at least two laminated layers of the dispensercomprise: a first layer; a second layer received against the firstlayer, the second and the first layers defining the passageway connectedto the exit port assembly, and one of the layers including a borecommunicating with the passageway; and the dispenser further includes apiston slidingly received in the bore.
 25. A device according to claim24, wherein the dispenser further comprises a spring biasing the pistontowards the passageway.
 26. A device according to claim 24, wherein thedispenser further comprises a magnetic coil received in one of thelayers coaxial with the piston for biasing the piston one of towards andaway from the passageway upon being energized.
 27. A device according toclaim 1, further comprising an inlet valve controlling flow from thereservoir into the accumulator, and an outlet valve controlling flowbetween the accumulator and the exit port assembly.
 28. A deviceaccording to claim 27, wherein the passageway includes openings for thevalves and the valves each include a layer of resilient fluid-tightmaterial covering the opening and a layer of piezoelectric materialcovering the layer of resilient fluid-tight material and arranged suchthat upon the piezoelectric material assuming one of a deformed stateand an undeformed state, the layer of piezoelectric material forces thelayer of resilient fluid-tight material into the opening of thepassageway and substantially closes the passageway.
 29. A deviceaccording to claim 27, wherein the dispenser further includes a barextending parallel with the passageway and pivotally mounted about apivot point, and wherein the valves comprise gates extending from thebar into the passageway on opposite sides of the pivot point.
 30. Adevice according to claim 27, wherein the valves comprise one-wayvalves.
 31. A device according to claim 30, wherein the valves compriseduck bill valves.
 32. A device according to claim 1, wherein thelaminated layers further define a bore bisecting the passageway and thedispenser further comprises a valve assembly including: a valve membermovably received in the bore and including an opening; a spring biasingthe valve member such that the opening of the valve member is normallyoffset from the passageway and the passageway is blocked by the valvemember; and an actuator for moving the valve member upon being actuatedsuch that the opening of the valve member aligns with the passageway.33. A device according to claim 32, wherein the actuator comprises a gasgenerator for pressurizing the bore upon being actuated.
 34. (Canceled)35. A device according to claim 1, wherein the reservoir contains atherapeutic fluid.
 36. A device according to claim 1, further comprisinga fill port connected to the reservoir.
 37. A device according to claim1, wherein the reservoir is pressurized.
 38. A device according to claim1, further comprising a transcutaneous patient access tool connected tothe exit port assembly.
 39. (Canceled)
 40. (Canceled)
 41. (Canceled) 42.(Canceled)
 43. A device according to claim 1, further comprising: aninlet valve connected to an inlet of the accumulator; a outlet valveconnecting an outlet of the accumulator to the exit port assembly; and apriming mechanism for maintaining the inlet valve and the outlet valvesimultaneously open.
 44. A device according to claim 43, wherein thepriming mechanism comprises: a pivotally movable first link operativelyconnected to the inlet valve such that the inlet valve is opened uponpivoting movement of the first link; a pivotally movable second linkoperatively connected to the outlet valve such that the outlet valve isopened upon pivoting movement of the second link; and a movable primingrod operatively connected to the first and the second links for pivotingthe links upon movement of the rod.
 45. A device according to claim 44,wherein: the inlet and the outlet valves each include a valve membermovable between open and closed positions; the first link extendsbetween the valve member of the inlet valve and the priming rod and ispivotally movable about a pivot point of the first link located betweenthe valve member of the inlet valve and the priming rod; the second linkextends between the valve member of the outlet valve and the priming rodand is pivotally movable about a pivot point of the second link locatedbetween the valve member of the outlet valve and the priming rod; andthe priming rod is linearly movable.
 46. A device according to claim 44,further comprising: a fill port adapted to receive a needle; and acollar connected to the priming rod and received in the fill port, thecollar adapted to receive a needle inserted into the fill port so thatthe inserted needle causes movement of the collar and the priming rodand pivoting movement of the links.
 47. A device according to claim 1,wherein the exit port assembly comprises a transcutaneous access toolhaving a known internal fluid volume.
 48. A device according to claim47, further comprising a processor controlling the dispenser, andwherein the processor is programmed to cause the dispenser to deliver avolume of fluid equal to the known internal fluid volume of the accesstool upon receiving a command.
 49. A device according to claim 47,further comprising a flow detector positioned between the dispenser andthe access tool.
 50. A device according to claim 49, further comprisinga processor controlling the dispenser and receiving signals from theflow detector, and wherein the processor is programmed to cause thedispenser to deliver a predetermined flow of fluid for a predeterminedperiod upon receiving a command and upon receiving a signal from theflow detector indicative of an initial flow of fluid to the access tool,the predetermined flow of fluid for the predetermined period producing avolume of fluid substantially equal to the known internal fluid volumeof the access tool.
 51. A device according to claim 47, furthercomprising a fluid detector positioned between the dispenser and theaccess tool.
 52. A device according to claim 51, further comprising aprocessor controlling the dispenser and receiving signals from the fluiddetector, and wherein the processor is programmed to cause the dispenserto deliver a predetermined volume of fluid upon receiving a command andupon receiving a signal from the fluid detector indicative of fluidinitially entering the fluid detector, the predetermined volume of fluidsubstantially equal to the known internal fluid volume of the accesstool.
 53. A device according to claim 47, wherein the access toolcomprises a needle.
 54. A device according to claim 1, furthercomprising a gas removal filter connected to the dispenser for removinggas bubbles from fluid entering the dispenser.
 55. (Canceled)
 56. Adevice according to claim 1, wherein the reservoir is gas permeable. 57.A device according to claim 1, further comprising: a fill portincluding, a passageway in fluid communication with the reservoir, avalve positioned within the passageway and allowing one-way flow intothe reservoir, and a removable septum sealing the passageway.
 58. Adevice according to claim 57, wherein the fill port further comprises afunnel having a small open end removably received in the passageway anda large open end receiving the septum.
 59. A device according to claim58, wherein the fill port further comprises a first wall having anopening removably receiving the large open end of the funnel when thesmall open end of the funnel is removably received in the passageway.60. A device according to claim 59, wherein the fill port furthercomprises a second wall spaced from the first wall more than a thicknessof the septum and having an opening allowing passage of a needle andpreventing passage of the septum.
 61. A device according to claim 57,wherein the fill port further comprises a first wall having an openingpreventing passage of the septum, and a second wall spaced from thefirst wall at least about a thickness of the septum and having anopening allowing passage of a needle, and wherein the second wall andthe opening of the second wall are adapted to allow passage of theseptum upon at least a predetermined force applied to the septum.
 62. Adevice according to claim 61, wherein the predetermined force is lessthan a force required to pull a needle out of the septum.
 63. A deviceaccording to claim 1, wherein the exit port assembly comprises aplurality of exit port assemblies and each assembly comprises anindependently deployable transcutaneous access tool adapted to providefluid communication with the dispenser upon deployment.
 64. A deviceaccording to claim 63, wherein each access tool comprises a needle. 65.A device according to claim 63, where each access tool is maintained ina sterile state prior to deployment.
 66. (Canceled)
 67. (Canceled) 68.(Canceled)
 69. (Canceled)
 70. (Canceled)
 71. (Canceled)
 72. (Canceled)73. (Canceled)
 74. (Canceled)
 75. (Canceled)
 76. (Canceled) 77.(Canceled)
 78. (Canceled)
 79. (Canceled)
 80. (Canceled)
 81. (Canceled)82. (Canceled)
 83. (Canceled)
 84. (Canceled)
 85. (Canceled) 86.(Canceled)
 87. (Canceled)
 88. (Canceled)
 89. (Canceled)